COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04331054

Camille TAILLE, MD, PhD

camille.taille@aphp.fr

2020-04-02

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criera : - patient ≥ 18 years old and ≤ 75 years old - laboratory proved infection by covid-19 by rt-pcr on a respiratory biological sample within 2 days - hospitalization is required according to current local recommendations - patient affiliated to a social security regime - patient able to give free, informed and written consent exclusion criteria : - oxygen flow rate >8l/min at inclusion - current treatment with any inhaled steroid (any other form of steroid administration does not exclude the patient) - intensive care unit is required for the patient (based on investigator judgement) - patient with cognitive impairment which do not guarantee proper use of the treatment by the patient himself - pregnant (positive β-hcg at inclusion) or breastfeeding women - participation in another interventional drug study involving human participants and concerning covid-19 infection or being in the exclusion period of a previous study involving human participants - contraindications to the treatments (history of hypersensitivity) - patient admitted for isolation, for social reason or due to comorbidities without gravity sign - long-term patient treated with digitalis, disopyramide, procainamide or phenothiazine that could lengthen the qt space

None

2

Assistance Publique - Hôpitaux de Paris

18

75

France

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

146

Time (in days) to clinical improvement within 30 days after randomization

None

Phase 3

[{"arm_notes": "", "treatment_id": 1435, "treatment_name": "Budesonide+formoterol", "treatment_type": "Corticosteroids+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]